The FDA has sent warning letters to two Chinese active pharmaceutical ingredient (API) manufacturers that refused to provide records upon request.
Chongqing Qiancan Technology (CQT) and Tianjin Healthcare Medical Technology (THM) each imported multiple shipments of APIs into the U.S. intended for compounding, the FDA said in its warning letters. The agency reached that conclusion after reviewing import records.
On June 17, the FDA emailed both companies to request records and other information. THM replied on June 24, telling the agency that it would discontinue the production of relevant products for the U.S. market and refusing to provide the requested documents.
The FDA repeated its request on June 25. As the agency explained, THM needed to provide the records because the company’s APIs were imported into the U.S. market and were still within their expiration date. Ceasing commercial distribution or expressing an intent to stop production did not retroactively relieve THM of its regulatory obligations, the FDA said. THM again refused to provide the requested records, according to the agency.
Meanwhile, CQT deregistered and discontinued its drug listing on June 29. The next day, the company told the FDA that it was unable to meet the agency’s requirements. CQT never provided the requested records. On July 13, CQT reregistered with the FDA.
On Aug. 26, the FDA issued import alerts for all drugs and drug products that CQT and THM offer to ship to the U.S. Officials generally detain imported drugs made by companies subject to import alerts. The policy of detaining imports without physical examination typically applies until the FDA completes an inspection.
The agency invited CQT and THM to schedule inspections. As of now, the FDA is unable to confirm the companies’ compliance with current good manufacturing practice (CGMP) and other applicable requirements, meaning it may withhold approval of new applications or supplements listing them as manufacturers.
Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that analytical testing service provider Eurofins ran for customers.
October 16, 2026
·
2 min read
·
The FDA published the notices alongside a warning letter that it sent to Nanjing Hanxin Pharmaceutical Technology (NHPT), another Chinese company that makes APIs for compounding in the U.S. Unlike CQT and THM, NHPT sent the records that the agency requested. The FDA’s review of the records revealed that NHPT’s quality unit failed to ensure that its APIs complied with CGMP.
NHPT’s supplier oversight is deficient because its quality unit failed to adequately qualify companies that provided critical raw materials, the FDA said. The agency also noted a potential attempt to “circumvent safeguards.” NHPT’s drugs are subject to an import alert.
Get a weekly update including our take on the most critical issues impacting manufacturing.
